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Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver

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ClinicalTrials.gov Identifier: NCT00039234
Recruitment Status : Unknown
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE June 6, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date December 18, 2013
Study Start Date  ICMJE September 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
Official Title  ICMJE A Phase III, Multi-Center Controlled Trial With Stratified Randomization Comparing The Efficacy Of Interleukin-2 (IL-2) Plus Histamine Dihydrochloride (HDC) Versus IL-2 Alone To Increase The Duration Of Survival In Patients With AJCC Stage IV Malignant Melanoma With Hepatic Metastasis
Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known if interleukin-2 is more effective with or without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the liver.

PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have stage IV melanoma that is metastatic to the liver.

Detailed Description

OBJECTIVES:

  • Compare the duration of survival in patients with stage IV melanoma with hepatic metastasis treated with interleukin-2 with or without histamine dihydrochloride.
  • Compare the progression-free survival, response rate, response rate of hepatic tumors, and lack of disease progression in patients treated with these regimens.
  • Determine the safety of these regimens, in terms of frequency, severity, and causal relationship of adverse events, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center location (North America vs Europe), lactate dehydrogenase (less than ULN vs ULN or greater), and metastatic sites (liver only vs liver and other sites). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive interleukin-2 (IL-2) subcutaneously (SC) twice daily on days 1 and 2 of weeks 1 and 3 and days 1-5 of weeks 2 and 4. Patients also receive histamine dihydrochloride SC over 10-30 minutes on days 1-5 of weeks 1-4.
  • Arm II: Patients receive IL-2 as in arm I. In both arms, treatment repeats every 6 weeks for at least 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 224 patients (112 per treatment arm) will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma (Skin)
  • Metastatic Cancer
Intervention  ICMJE
  • Biological: aldesleukin
  • Drug: histamine dihydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV melanoma

    • Must have radiological evidence of lesions in liver (target or non-target)
  • At least 1 measurable lesion outside previously irradiated field

    • At least 20 mm by contrast-enhanced CT scan, MRI, medical photography, or physical exam OR at least 10 mm by spiral CT scan
  • No prior or concurrent clinical and/or objective evidence of brain metastasis

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-1

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Hemoglobin at least 9.5 g/dL
  • WBC at least 3,000/mm^3
  • Granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST and ALT no greater than 4 times ULN
  • Alkaline phosphatase no greater than 4 times ULN
  • Hepatitis B and C negative

Renal:

  • Creatinine no greater than 1.7 mg/dL
  • Calcium no greater than 11.5 mg/dL

Cardiovascular:

  • No abnormal thallium stress test
  • No acute myocardial infarction within the past year
  • No New York Heart Association class III or IV heart disease

Pulmonary:

  • No asthma requiring active treatment within the past 5 years
  • Oxygen saturation by pulse oximeter at least 90% unless FEV_1 is greater than 2 L or at least 75% predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • Concurrent medically-controlled (except with glyburide) or diet-controlled diabetes is allowed
  • Concurrent medically-controlled thyroid dysfunction is allowed
  • No other active malignancy within the past 5 years except carcinoma in situ of the cervix or localized squamous cell or basal cell skin cancer
  • No serious non-malignant medical conditions, including psychiatric disability, that would preclude study compliance
  • No active autoimmune disease (e.g., lupus, inflammatory bowel disease, or psoriasis)
  • No active peptic and/or esophageal ulcer disease
  • No hypersensitivity to histamine products or urticaria
  • No active IV drug abuse

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy with high-dose IV interleukin-2 (IL-2)
  • No prior combination immunotherapy with chemotherapy
  • At least 1 year since prior low-dose adjuvant IL-2 as part of vaccine therapy or as therapy for stage II or III melanoma

Chemotherapy:

  • See Biologic therapy

Endocrine therapy:

  • No chronic systemic glucocorticoid steroids

    • Asthma inhalers, topical creams, or intra-articular injections allowed
  • Hormonal therapy for non-melanoma-related conditions allowed

Radiotherapy:

  • See Disease Characteristics
  • Concurrent radiotherapy as palliative therapy for isolated non-target lesions (e.g., bone lesions) allowed

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior therapy directed at malignancy
  • At least 4 weeks since prior investigational medications or therapies
  • At least 2 weeks since prior parenteral antioxidants and/or vitamins
  • At least 2 weeks since prior antibiotics for active illness
  • At least 2 weeks since prior H2 antagonists, beta-blockers, antihypertensives, antimalarials, antitrypanosomals, neuromuscular-blocking agents, tricyclic antidepressants, or alprazolam
  • At least 24 hours since prior antihistamines
  • No prior enrollment in any Maxim Pharmaceuticals investigational trials
  • No concurrent anticonvulsant therapy for seizure disorder
  • No other concurrent investigational drug
  • No concurrent H2 antagonists, tricyclic antidepressants, alprazolam, beta- blockers, antihypertensives, antitrypanosomals, antimalarials, or monoamine oxidase inhibitors
  • No concurrent inhibitors of diamine oxidase, monoamine oxidase, or histamine N-methyltransferase
  • No concurrent antihistamines
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00039234
Other Study ID Numbers  ICMJE CDR0000069365
MAXIM-MP-8899-0104
UCLA-0111056
NCI-G02-2070
MSKCC-03057
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Maxim Pharmaceuticals
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP